Daytime Severe Cold And Flu Capsule, Liquid Filled (acetaminophen 325mg, Guaifenesin 200mg, Dextromethorphan Hbr 10mg, Phenylephrine Hcl 5mg)

Daytime Severe Cold And Flu Capsule, Liquid Filled (acetaminophen 325mg, Guaifenesin 200mg, Dextromethorphan Hbr 10mg, Phenylephrine Hcl 5mg)
SPL v1
SPL
SPL Set ID de4d25ea-6f0e-49d8-b2ad-fdccf95f54ca
Route
ORAL
Published
Effective Date 2021-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 1) Phenylephrine (5 1)
Inactive Ingredients
Polyethylene Glycol 400 Propylene Glycol Povidone K30 Fd&c Yellow No. 6 Titanium Dioxide Gelatin Glycerin Sorbitol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-03-01

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine Hydrochloride 5 mg

Purpose

Pain reliever/ fever reducer Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever/ fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine Hydrochloride 5 mg

Uses
  • temporarily relieves common cold/flu symptoms:

      ο   nasal congestion

      ο   sinus congestion & pressure

      ο   cough due to minor throat & bronchial irritation

      ο   minor aches & pains

      ο   headache

      ο   fever

      ο   sore throat

  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Warnings:

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

more than 4 softgels in 24 hours, which is the maximum daily amount for this product

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hours

adults & children 12 years of age and over 2 softgels with water every 4 hours
Children under 12 years of age  ask a doctor

When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Do Not Use
  • with any other drug containing acetaminophen (prescription or nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Overdose Warning:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information:
  • store at room temperature 59°-86°F (15°-30°C)
Inactive Ingredients

polyethylene glycol 400, propylene glycol, povidone k30, fd&c yellow no. 6, titanium dioxide, gelatin, glycerin, sorbitol, water

Stop Use and Ask A Doctor If
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Active Ingredients (in Each Capsule)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine Hydrochloride 5 mg

Principal Display Panel Shipping Label

Acetaminophen, Dextromethorphan HBr, Guifenesin, Phenylephrine HCL capsules

Each Softgel Contains:

(Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg, Guifenesin 200mg, Phenylephrine Hydrochloride USP 5mg)

LOT NO:

DRUM NO:

MFG DATE:

QUANTITY:

NDC NO: 55629-015-

EXP DATE:

WARNING:

KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)

PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.

CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH

THE F.D & C.ACT AND REGULATIONS THEREUNDER.


Structured Label Content

Uses
  • temporarily relieves common cold/flu symptoms:

      ο   nasal congestion

      ο   sinus congestion & pressure

      ο   cough due to minor throat & bronchial irritation

      ο   minor aches & pains

      ο   headache

      ο   fever

      ο   sore throat

  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Purpose

Pain reliever/ fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Warnings:

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

more than 4 softgels in 24 hours, which is the maximum daily amount for this product

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hours

adults & children 12 years of age and over 2 softgels with water every 4 hours
Children under 12 years of age  ask a doctor

When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Do Not Use
  • with any other drug containing acetaminophen (prescription or nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Overdose Warning: (Overdose warning:)

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information:
  • store at room temperature 59°-86°F (15°-30°C)
Inactive Ingredients (Inactive ingredients)

polyethylene glycol 400, propylene glycol, povidone k30, fd&c yellow no. 6, titanium dioxide, gelatin, glycerin, sorbitol, water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Active Ingredients (in Each Capsule) (Active ingredients (in each capsule))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine Hydrochloride 5 mg

Principal Display Panel Shipping Label (PRINCIPAL DISPLAY PANEL - Shipping Label)

Acetaminophen, Dextromethorphan HBr, Guifenesin, Phenylephrine HCL capsules

Each Softgel Contains:

(Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg, Guifenesin 200mg, Phenylephrine Hydrochloride USP 5mg)

LOT NO:

DRUM NO:

MFG DATE:

QUANTITY:

NDC NO: 55629-015-

EXP DATE:

WARNING:

KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)

PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.

CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH

THE F.D & C.ACT AND REGULATIONS THEREUNDER.


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